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Hitachi Altaire

by Hitachi Medical Systems America, Inc. 2 variants

510(k) K022390

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK022390 Date11 Oct 2002ClearedStatusActive

Recalls

5 recalls · FDA

    • Terminated Z-0910-06 FDA Unclassified (pre-2012) initiated 21 Feb 2006

    The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.

    • Terminated Z-1103-06 FDA Unclassified (pre-2012) initiated 27 Jan 2006

    Circuit Failure-There is the potential risk of the Phase Loss Detector Safety Device (PHSEN PCB) malfunctioning in the event of a power loss. The circuit may fail to turn off the system main breaker when 2 of the 3 power phases are lost.

    • Terminated Z-0888-05 FDA Unclassified (pre-2012) initiated 30 Jun 2005

    Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.

    • Terminated Z-0797-05 FDA Unclassified (pre-2012) initiated 11 Apr 2005

    The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard.

    • Terminated Z-0846-05 FDA Unclassified (pre-2012) initiated 18 Nov 2004

    The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Hitachi Altaire is a Nuclear Magnetic Resonance Imaging (MRI) System, designed for diagnostic imaging of the human body using strong magnetic fields and radio waves. It generates detailed images of organs, tissues, and skeletal structures to aid in the detection and evaluation of medical conditions, including musculoskeletal, neurological, and cardiovascular disorders.

This MRI system is intended for use in clinical radiology settings and is supplied as a reusable medical device. It operates under FDA 510(k) clearance as a Class 2 device, with regulatory classification under 892.1000. The system is not single-use and requires proper maintenance, calibration, and adherence to MRI safety protocols, including compliance with magnetic field strength and spatial parameters. Storage and handling must follow manufacturer guidelines to ensure optimal performance and patient safety.

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